Biomarkers in Breast Cancer-microRNA profiling and Omics analysis

Not yet recruiting

Conditions: Malignant neoplasm of breast,

Registration Number: CTRI/2024/01/061792

Lead Sponsor: Government Mohan Kumaramangalam Medical College

Brief Summary: Breastcancer (BC) is the most common cancer among women, with approximately 2.3 millionnew cases and over 685,000 deaths worldwide in 2020. India is no exception.Risk factors include age, genetics, and lifestyle choices. Challenges in Indiainclude relatively younger age of onset, late-stage diagnosis, limited accessto quality healthcare in rural areas, and lack of awareness about symptoms andrisk factors. Treatment options include surgery, chemotherapy, radiation, andhormonal therapies. Research on early detection and effective targetedtherapies is the need of the hour to improve overall and disease-free survivalrates.

MicroRNA(miR) profiling is a valuable tool in breast cancer research and clinicalpractice to analyse the expression levels of microRNAs (miRNAs) in breastcancer tissue. The role of miR profiling in breast cancer includes thefollowing:

1.       **Biomarker Discovery**: MicroRNAprofiling helps identify specific miRNAs that are either overexpressed orunderexpressed in breast cancer tissue. These miRNAs can serve as potentialbiomarkers for diagnosis, prognosis, and predicting treatment responses.

2.       **Molecular Subtyping**: MicroRNAprofiles can aid in classifying breast cancer into different molecularsubtypes, such as luminal, HER2-enriched, and triple-negative. Thisclassification is crucial for tailoring treatment strategies to the uniquecharacteristics of the tumour.

3.       **Prognostication**: Certain miRNAexpression patterns are associated with different outcomes in breast cancerpatients. High or low expression of specific miRNAs can indicate a better orworse prognosis, assisting healthcare professionals in making informedtreatment decisions.

4.       **Identification of Therapeutic Targets**:MicroRNA profiling can reveal miRNAs that play a significant role in cancerprogression, metastasis, and drug resistance. Targeting these miRNAs withtherapeutic interventions or drugs may offer new avenues for breast cancertreatment.

5.       **Personalized therapies**: Byanalysing a patient’s microRNA profile, personalized treatment strategiestargeting the unique genetic characteristics of a patient’s breast cancer arepossible, potentially leading to improved survival.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

1.Consecutive patients with newly detected breast cancer- planned for surgery (MRM or BCT) or Neo-adjuvant chemotherapy 2.Age and sex-matched subjects without breast cancer.

Exclusion Criteria

1.Known case of Breast cancer previously treated with surgery, chemotherapy or radiotherapy 2.Previous history of treatment for non-breast cancer 3.Patients with unsound mind 4.Patients not willing.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Diagnostic microRNA in breast cancer patients versus healthy adults such as miR-16, miR-19b, miR-106a, miR-21, miR-1246, miR-939, miR-373, miR-101, miR155, let-7 family of miR125b, miR100, miR34a, miR-335	1. Early Breast Cancer \| Before Surgery \| Before Adjuvant Chemotherapy \| Before Adjuvant Radiotherapy \| 3-month post-chemoradiotherapy \| 2.Locally Advanced Breast cancer \| Before neoadjuvant therapy \| Before Surgery \| Before Adjuvant Chemotherapy \| Before Adjuvant Radiotherapy \| 3-month post-CRT \| 3. Metastatic Breast Cancer \| Before and after palliative therapy
2. Prognostic microRNA in Breast Cancer such as miR-16, miR-19b, miR-106a, miR-21, miR-1246, miR-939, miR-373, miR-101, miR155, let-7 family of miR125b, miR100, miR34a, miR-335	1. Early Breast Cancer \| Before Surgery \| Before Adjuvant Chemotherapy \| Before Adjuvant Radiotherapy \| 3-month post-chemoradiotherapy \| 2.Locally Advanced Breast cancer \| Before neoadjuvant therapy \| Before Surgery \| Before Adjuvant Chemotherapy \| Before Adjuvant Radiotherapy \| 3-month post-CRT \| 3. Metastatic Breast Cancer \| Before and after palliative therapy

Secondary Outcome Measures

Name	Time	Method
microRNA (miR) profile- Early BC markers-miR-16 and miR-106a, a miR-19b-based 3-circulating miRNA	miR profile - Invasive Breast Cancer-miR-12, miR-1246

Trial Locations

Locations (1): Government Mohan Kumaramangalam Medical College Hospital
🇮🇳
Salem, TAMIL NADU, India
Government Mohan Kumaramangalam Medical College Hospital
🇮🇳Salem, TAMIL NADU, India
Dr Poongkodi Karunakaran MS MCh PhD
Principal investigator
9443119743
poongkodithesurgeon@gmail.com